跳至主要内容
临床试验/NCT06541873
NCT06541873尚未招募不适用

DuALS - A Cross-sectional Observational Study of Gait Patterns in Dual-task Conditions in Patients With Amyotrophic Lateral Sclerosis

IRCCS San Raffaele0 个研究点目标入组 60 人开始时间: 2024年9月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
Dual-task cost at Timed Up and Go performance

研究概览

简要总结

The investigators hypothesize a relevant impact of cognitive status over gait performance in patients with amyotrophic lateral sclerosis (ALS), contributing to poor mobility and representing a relevant risk for falls. The present observational, cross-sectional study on ambulatory patients with ALS will evaluate gait performance using different sets of dual-task conditions to demonstrate the importance of cognitive aspects in rehabilitation programs for these patients. The dual-task conditions to be assessed during gait performance will include: counting backwards by 3 (executive simple task); counting backwards by 7 (executive complex task); mnemonic recall of the Rey's Auditory Verbal Learning Test (RAVLT). Patients' performance will be compared with a group of healthy controls with similar age and sex distribution in order to highlight the specific effects of the disease.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Dual-task cost at Timed Up and Go performance

时间窗: Cross-sectional (baseline) evaluation

Percentage of variability of gait scores obtained at the Timed Up and Go (TUG) test (i.e., time in seconds) in dual-task vs. single-task conditions in ALS patients compared with healthy controls

Dual-task cost at 1-Minute Walking Test performance

时间窗: Cross-sectional (baseline) evaluation

Percentage of variability of gait scores obtained at the 1-Minute Walking Test (1minWT) (i.e., meters walked in one minute) in dual-task vs. single-task conditions in ALS patients compared with healthy controls

次要结局

  • Executive complex task(Cross-sectional (baseline) evaluation)
  • Muscle strength(Cross-sectional (baseline) evaluation)
  • Executive simple task(Cross-sectional (baseline) evaluation)
  • Walking velocity(Cross-sectional (baseline) evaluation)
  • Mnemonic ability(Cross-sectional (baseline) evaluation)
  • Functional disability(Cross-sectional (baseline) evaluation)
  • Cognitive impairment(Cross-sectional (baseline) evaluation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Massimo Filippi

MD, Professor

IRCCS San Raffaele

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